Donielle McCutcheon

Jul 5, 2024 | mddionline.com | Donielle McCutcheon |Taylor Andelman

Recruiting and retaining study subjects remains a significant challenge for medical device companies that are innovating and sponsoring clinical trials, particularly when designing studies that reflect the diversity of the national population. Difficulties enrolling eligible study subjects can lead to significant study delays and can be costly for trial sponsors, extending the timeline that patients need to wait to obtain access to safe, effective, and important medical technologies.

Jul 1, 2024 | mddionline.com | Donielle McCutcheon |Taylor Andelman

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Jan 8, 2024 | lexology.com | Meenakshi Datta |Brenna Jenny |Donielle McCutcheon |Catherine Y. Starks |Kwaku Akowuah |Matthew Guillod

In late December 2023, the U.S. District Court for the District of Columbia issued an order that has important implications for pharmaceutical manufacturers that offer co-pay assistance for eligible patients.

Jul 17, 2023 | lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +1 more

In the past two weeks, the Centers for Medicare & Medicaid Services (CMS) unveiled important details regarding implementation of the Medicare Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act (IRA).

Jun 22, 2023 | pharmaceuticalonline.com | Donielle McCutcheon |Kim Schroer |Carol Houts |Satu Lakio

By Donielle McCutcheon and Kim Schroer, Sidley Austin LLP For emerging drug companies on a tight budget, an effective healthcare compliance program can save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in precommercial stages and will prepare you for the regulated future ahead.